ebA Multivitamin Recalled for Undeclared Milk Ingredients
Saratoga Therapeutics is recalling ebA Multivitamin tablets because they contain milk components despite labeling stating they are free of milk.
The agency’s classification
FDA (Food): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "The recall was initiated due to discovery of the presence of milk components (milk protein(s) and lactose) despite labeling that incorrectly states it is free of milk components."
Plain-English summary
Saratoga Therapeutics, LLC is recalling ebA Multivitamin Supplement, 180 tablets in plastic bottles. The recall was initiated after the discovery of milk components, specifically milk proteins and lactose, in the product. This is a safety issue because the product labeling incorrectly states that it is free of milk components.
The affected product includes lot numbers 0912164 (expiration 12/12) and 1110354 (expiration 10/14). A total of 890 bottles were distributed. The product was sold through physicians' offices and via internet sales to consumers located nationwide and in Canada.
Consumers who have purchased this product should stop using it and contact Saratoga Therapeutics, LLC for further instructions or a refund. Individuals with a milk allergy or sensitivity should be particularly cautious, as the presence of undeclared milk proteins poses a risk of allergic reaction.
The recalled product
- Product
- ebA*(TM) Multivitamin Supplement, 180 tablets in plastic bottles, Distributed by Saratoga Therapeutics, LLC, North Wales, PA.
- Manufacturer
- Saratoga Therapeutics, LLC
- Category
- Food — Dietary Supplement
- Affected units
- 890
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot number 0912164
- exp 12/12 and 1110354
- exp 10/14
Distribution
Distributed nationwide across the United States.
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